Effects of skin electrical stimulation at acupuncture points PC6, ST36 and LI4 on hemodynamics, pain, nausea and vomiting during anesthesia in patients requiring elective laparoscopic cholecystectomy

Determining the effects of electrical skin stimulation at acupuncture points PC6, ST36 and LI4 on hemodynamics, pain, nausea and vomiting during general anesthesia in patients requiring elective laparoscopic cholecystectomy

This study is a double - blind randomized clinical trial in phase 3 with two groups of control and intervention that will be conducted on 70 patients need general anesthesia. Random allocation will be done using random letters and computer software.

The study is conducted on elective patients who are candidates for general anesthesia in teaching hospitals in Kermanshah. In the intervention group, active electrical stimulation is performed on acupuncture points during the patient's anesthesia. In the control group, electrical stimulation is not performed. Patients and the researcher recording the data are unaware of the grouping and type of intervention.

Inclusion criteria: patients who need surgery for cholecystectomy and general anesthesia; reading and writing literacy; verbal ability and healthy vision; healthy skin healthy. Exclusion criteria: history of smoking and opioids؛ use of analgesics and antiemetic drugs during the past 24 hours; history of diabetes and cardiovascular disease; having a pacemaker.

In the control group (C), during anesthesia, electrodes are connected bilaterally to acupuncture points in the PC6, ST36, and LI4 areas of the patients, but the stimulation device is inactive and turned off. In the intervention group (I), bilateral electrical stimulation at the aforementioned acupuncture points continues simultaneously from 10 minutes before anesthesia induction until the end of anesthesia and recovery.

Blood pressure changes; heart rate changes; pain intensity; amount of analgesia taken; severity of nausea and vomiting

Updating study start and end dates

Randomization of samples in this study is done by the Randomization Main computer software. Given the presence of two groups, a random sequence of the letters I and C is created in blocks with a random number of 2 letters. Each letter symbolizes one of the study groups. Then these blocks are placed in sealed envelopes. One of the blinded researchers opens one of the envelopes before the start of the study and finally the patient is placed in one of the groups.

In the control group (C); the electrodes of the electrical stimulation device are placed at the acupuncture points, but the stimulation device is inactive. In the intervention group (I); the stimulation electrodes are placed at the acupuncture points and connected to the electrical stimulation device with active function. Due to the identical apparent interventions and the patient's lack of knowledge of the stimulation group and intervention, the patients were blinded to the intervention. In the control group, the stimulation device is turned off and no real stimulation is applied. Given that the patients in the intervention group may feel the stimulation, the current threshold level is considered minimal. In addition, most of the stimulation period occurs during the patient's anesthesia and the patient is not conscious and alert. Electrical stimulation is performed by one study colleague and the recording of study variables is performed by another study colleague who was blinded to the grouping. Therefore, two study assistants are observed.